Dry EyeNCT00848068
Evaluation of FID 114657 on Tear Film Lipid Layer Thickness
A study testing FID 114657 and OPTIVE Lubricant Eye Drops in people with Dry Eye, run by Alcon Research.
Trial summary
To evaluate the effects of FID 114657 on the tear film lipid layer thickness of patients with dry eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- FID 114657 and OPTIVE Lubricant Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent document and HIPAA privacy document must be read, signed and dated by the patient or legally authorized representative before conducting any procedures.
- Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following characteristics:
- Positive response to the question, "Do you ever feel your eyes?";
- Baseline LLT value of ≤75nm (OU), not varying by more than ±15 nm over the course of a 10-minute observation period, difference in LLT between the two eyes must be ≤15nm, and increase in LLT after three forceful blinks must be ≤15nm.
- Patients must have best-corrected Snellen visual acuity of 20/70 or better in each eye.
- Able and willing to follow study instructions.
Who cannot join
- Use of topical ocular drops within 12 hours of the study visit; or use of a topical ocular ointment within 36 hours of the study visit. In addition, use of any concomitant topical ocular drugs during the study period.
- History or evidence of ocular or intraocular surgery in either eye within the past six months.
- History or evidence of serious ocular trauma in either eye within the past six months.
- History of intolerance or hypersensitivity to any component of the study medications.
- History of and/or current evidence of glaucoma or ocular hypertension in either eye.
- History of and/or current evidence of active intraocular inflammation in either eye (i.e., retina/macula/choroid).
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- History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
- Ocular conditions such as active acute blepharitis, conjunctival infections, iritis, conjunctival abnormalities (including pinguecula greater than 1mm in diameter, located closer than 2mm to the limbus or elevated more than 0.2mm), eyelid abnormalities (including entropion and ectropion) or any other ocular condition that may, in the opinion of the investigator, preclude the safe administration of the test articles.
- Patients using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to the study visit.
- Any ocular or systemic medical condition that might influence the tear film (other than dry eye).
- Individuals unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued a minimum of 12 hours prior to the study visit.
- Individuals unwilling to discontinue use of cosmetics (such as eyeliner, mascara or eye shadow) or facial creams on or around the eyelids on the day of the study.
- Participation in an investigational drug or device study within 30 days of entering this study.
About this study
To evaluate the effects of FID 114657 on the tear film lipid layer thickness of patients with dry eye.
- Conditions
- Dry Eye
- Being tested
- FID 114657, OPTIVE Lubricant Eye Drops
- Keywords
- lipid layer thickness
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID 114657Other
artificial tears
OPTIVE Lubricant Eye DropsOther
artificial tears
| Study group | Role | What they receive |
|---|---|---|
| OD (Right Eye) | Other | FID 114657 or OPTIVE Receives: Other: FID 114657; Other: OPTIVE Lubricant Eye Drops |
| OS (Left eye) | Other | FID 114657 or OPTIVE Receives: Other: FID 114657; Other: OPTIVE Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid layer thickness
Measured: Instill assigned test article to the right eye and begin timing the examination process. Measure lipid layer thickness at 1 minute, 5 minutes, 15 minutes and 60 minutes post instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848068
- Sponsor's protocol ID
- C-07-61
- Status last verified
- Feb 2012
- First submitted
- 19 Feb 2009
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of FID 114657 on Tear Film Lipid Layer Thickness
- ClinicalTrials.gov ID
- NCT00848068
- Acronym / sponsor ID
- C-07-61
- Conditions
- Dry Eye
- Keywords
- lipid layer thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effects of FID 114657 on the tear film lipid layer thickness of patients with dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OD (Right Eye) | Other | Other: FID 114657, Other: OPTIVE Lubricant Eye DropsFID 114657 or OPTIVE |
| OS (Left eye) | Other | Other: FID 114657, Other: OPTIVE Lubricant Eye DropsFID 114657 or OPTIVE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent document and HIPAA privacy document must be read, signed and dated by the patient or legally authorized representative before conducting any procedures.
- Patients (minimum age 18) with dry eye. Criteria for the diagnosis must include the following characteristics:
- Patients must have best-corrected Snellen visual acuity of 20/70 or better in each eye.
- Able and willing to follow study instructions.
Key exclusion criteria (13 listed)
- Use of topical ocular drops within 12 hours of the study visit; or use of a topical ocular ointment within 36 hours of the study visit. In addition, use of any concomitant topical ocular drugs during the study period.
- History or evidence of ocular or intraocular surgery in either eye within the past six months.
- History or evidence of serious ocular trauma in either eye within the past six months.
- History of intolerance or hypersensitivity to any component of the study medications.
- History of and/or current evidence of glaucoma or ocular hypertension in either eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FID 114657artificial tears | Other | OD (Right Eye), OS (Left eye) |
| OPTIVE Lubricant Eye Dropsartificial tears | Other | OD (Right Eye), OS (Left eye) |
Primary outcome
lipid layer thickness
Time frame: Instill assigned test article to the right eye and begin timing the examination process. Measure lipid layer thickness at 1 minute, 5 minutes, 15 minutes and 60 minutes post instillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FID 114657 and OPTIVE Lubricant Eye Drops in people with Dry Eye, run by Alcon Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lipid layer thickness (time frame: Instill assigned test article to the right eye and begin timing the examination process. Measure lipid layer thickness at 1 minute, 5 minutes, 15 minutes and 60 minutes post instillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.